Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity

Obesity Clinical Trial

Official title:

Effect of Oral L-Citrulline Supplementation on Liver Function and Non-Alcoholic Fatty Liver Disease in Adolescents With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871360
• Other study ID #: NAFLD-CITRULLINE
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the comorbidities of obesity is nonalcoholic fatty liver disease (NAFLD). L-citrulline is a non-protein amino acid that has shown positive effects on the degree of fat retention and metabolic profile in NAFLD. The objective is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo and an experimental group that will receive 6 g of l-citrulline per day for eight weeks.

Description:

It is hypothesized that l-citrulline supplementation decreases liver enzymes and the degree of hepatic steatosis in adolescents with obesity. The aim of the study is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A prospective randomized, double-blind clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo (carboxymethyl cellulose) and an experimental group that will receive 6 g of pure l-citrulline per day per eight weeks. At the beginning and end of the intervention, anthropometric, biochemical and metabolic data will be evaluated, as well as tests of function and degree of hepatic steatosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 15, 2022
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• Adolescents between 15 and 19 years old, residents of the city of León, Guanajuato, with obesity due to BMI =30 kg / m2 equivalent to the categorization of adults. That they are in stage 5 of Tanner scale with diagnosis of mild, moderate or severe NAFLD and / or alterations in liver enzyme levels. Not be under nutritional treatment, not be smokers, not taking multivitamins, if so, a wash time of 30 days will be given. Not be allergic to l-citrulline or watermelon. Alcohol consumption less than 21 standard drink units for men and 14 standard drink units for women per week (Standard drink: any drink with more than 14 g of pure alcohol).

Exclusion Criteria:

• Present intolerance to l-citrulline or allergy to watermelon.

• Have an adherence of less than 80 percent of the treatments.

• Present other causes of liver disease.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity

Intervention

Dietary Supplement:
• L-Citrulline supplement
The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
• Carboxymethyl cellulose supplement
The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.

Locations

Country	Name	City	State
Mexico	University of Guanajuato	León	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Guanajuato

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of hepatic steatosis	The degree of hepatic steatosis will be evaluated by abdominal ultrasound. It will be diagnosed as: Mild, when an increase in echogenicity and hepatomegaly are observed.; Moderate, when sound attenuation is added.; Severe, when the wall of the portal vessels and the diaphragm are not visible.	Baseline to 8 weeks
Secondary	Glucose	Glucose will be evaluated by the GOD-PAD Lakeside glucose oxidase method.	Baseline to 8 weeks
Secondary	Insulin	The insulin level will be measured by ELISA (ALPCO) method. The HOMA-IR index will be calculated to determine insulin resistance.	Baseline to 8 weeks
Secondary	Insulin resistance	The HOMA-IR index to determine insulin resistance will be calculated from serum glucose and insulin levels.	Baseline to 8 weeks
Secondary	Lipid profile	The lipid profile will be measured by the modified Huang method of the Spinreact brand.	Baseline to 8 weeks
Secondary	LDL-cholesterol	LDL-cholesterol will be determined using the Friedwald formula.	Baseline to 8 weeks
Secondary	Urea levels	Urea levels will be obtained by the Urease GLDH kinetic method.	Baseline to 8 weeks
Secondary	Uric acid levels	Uric acid will be evaluated by peroxidase enzymes and colorimetry.	Baseline to 8 weeks
Secondary	Liver function	Liver function will be evaluated using the liver enzymes alanine aminotransferase and aspartate aminotransferase by the UV enzymatic kinetic method, as well as with alkaline phosphatase by the optimized kinetic method and direct bilirubin by the DMSO method (dimethyl sulfoxide-Malloy-Evelyn reaction).	Baseline to 8 weeks